Bendamustine is used in the treatment of a number of cancers including leukemias, Hodgkin's disease and multiple myelomas. Bendamustine, (present as the HCl salt) is the active ingredient of the commercial product Treanda™, a lyophilized powder for reconstitution. Current labeling requirements call for the reconstituted product to be immediately (within 30 minutes) diluted into 500 mL of parenterally acceptable diluents such as 0.9% saline (normal saline) or 2.5% dextrose/0.45% saline and administered as part of an intravenous infusion delivering 100 mg/m2 over 30 minutes or 120 mg/m2 over 60 minutes. The diluted admixture may be stored at 2-8° C. for up to 24 hours, or 3 hours at room temperature (15-30° C.); administration must be completed within this period due to limited chemical stability in aqueous solutions.
Higher infusion volume and longer infusion times, however, are associated with many drawbacks. For example, currently available bendamustine therapies with their larger intravenous administration volumes and sodium loads can be contraindicated in patients who have significant cardiac disease such as congestive heart failure and/or renal failure. Thus, some patients who would benefit from bendamustine therapy cannot take the drug or, if there are no alternative therapies, are exposed to significant physical harm as a result of receiving large volumes of sodium-containing fluid along with the bendamustine. The higher infusion volumes cause unhealthy stress on diseased organs including the heart and kidney in these patients. It would be most advantageous if the drug could be administered in smaller volumes and over shorter times to patients needing the drug but also requiring fluid and sodium intake restrictions. The present invention addresses this need.